Mumbai: The Bombay High Court has set aside orders issued by the Maharashtra Food and Drug Administration (FDA) and the Central Drugs Standard Control Organisation (CDSCO) that had forced National Pharmaceuticals and Aveo Pharmaceuticals to halt production of all medicines, including those containing painkillers Tapentadol and Carisoprodol.
Court Slams Violation of Natural Justice
Justice N.J. Jamadar, while delivering the verdict, held that the stop-production directives were in “flagrant violation” of the principles of natural justice. The court pointed out that the regulators had breached Rule 85(2) of the Drugs and Cosmetics Rules, 1945, which mandates that no licence can be suspended or revoked without first giving the manufacturer an opportunity to be heard.
Companies Challenge Sweeping Orders
The petitions were filed against the February 12, 2025 orders which had brought all manufacturing operations at the firms to a standstill. The orders were based on a DGHS advisory that flagged misuse of Tapentadol-Carisoprodol products and their alleged diversion into illicit West African markets. Following this, CDSCO and the FDA carried out inspections and imposed immediate bans.
Background: DCGI’s Earlier Ban
Earlier, the Drugs Controller General of India (DCGI) had banned the production and export of unapproved combination drugs containing Tapentadol and Carisoprodol. A joint CDSCO-FDA audit of Aveo Pharmaceuticals between February 21 and 22, 2025, subsequently led to a Stop Activity Order, freezing all operations at the company’s facilities.
Pharma Firms Term Orders Arbitrary
Both companies argued that the regulators’ actions were arbitrary and disproportionate. They contended that they had already surrendered licences for Tapentadol-Carisoprodol products and submitted compliance reports. Despite this, authorities extended the suspension to all manufacturing, effectively crippling their businesses. Crucially, the stop orders were issued before any show-cause notices, which arrived only on February 14.
Court Observes Overreach
Reviewing the petitions, the High Court noted that the prohibition was issued without prior notice, making the regulators’ stance untenable. “The impugned actions of prohibiting the manufacture, sale and distribution of all the medicinal products were in clear violation of the statutory requirements. The orders are too fragile to merit countenance,” the court said.
Due Process Must Prevail, Says HC
Justice Jamadar underscored that administrative authorities must respect due process, even when acting in the interest of public health. The judgment emphasised that actions affecting fundamental rights and livelihoods cannot bypass legal safeguards. The court also observed that extending the prohibition to all operations, when licences for the specific painkillers had already been surrendered, was excessive and unwarranted.
Regulators Allowed to Act Afresh
While quashing both the February 2025 stop-production orders and the July 2025 confirmations, the court clarified that regulators are not barred from future action. “The Competent Authority may pass appropriate orders in relation to the proposed action of cancellation or suspension of the manufacturing license pursuant to the show-cause notice… in accordance with law,” the ruling stated.
